Reducing Antibiotic Resistance: Improved Diagnostics and Treatment for Uncomplicated Urinary Tract Infection in General Practice, Denmark
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 377
- 试验地点
- 1
- 主要终点
- The proportion of patients receiving correct treatment
研究概览
简要总结
The purpose of this study is to determine whether point-of-care susceptibility testing improve correct choice of antibiotics, clinical and microbiological outcome in patients with uncomplicated urinary tract infection in general practice compared to point-of-care urine culture.
详细描述
700-900 patients with symptoms of uncomplicated urinary tract infection, consecutively contacting their GP, randomized to either point of care test (POCT) urine culture and empirical treatment or POCT urine culture and susceptibility testing and targeted treatment. Patients are included until 440 with verified positive cultures are included. The two groups are compared with regard to correct choice of antibiotics, clinical remission and microbiological cure rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adult patients
- •18 years or older
- •Presenting at their GP with dysuria
- •Frequency or urgency, which have been present for 7 days or less and where the GP suspects uncomplicated UTI.
- •Patients should be able to deliver a mid-stream urine sample, to provide informed consent and be willing and able to fill out a symptom diary.
排除标准
- •Negative dipstick analysis
- •Complicated urinary tract infection
- •Known pregnancy
- •Severe systemic symptoms, high fever, flank pain
- •Recent bladder surgery (within past 4 weeks)
- •Urinary tract abnormalities
- •Serious systemic disease
- •Life-threatening cancer
- •Insulin dependent diabetes
- •Long-term corticosteroid treatment
- •Other conditions with compromised immunity
- •Former participation in the study
- •Patients presenting on a Friday (since the POCT must be read after 24 hours)
结局指标
主要结局
The proportion of patients receiving correct treatment
时间窗: 12 months
Correct treatment defined as: 1. If an antibiotic is given, there is significant growth of one or more organisms in the gold standard, which all are sensitive to the given antibiotic. The antibiotic must be one of the recommended first-choice treatments unless the organism(s) is/are resistant to or the patient is allergic 2. If no antibiotic is given, there is no significant growth in the gold standard
次要结局
- The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)(14 months)
- -The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)(14 months)
- Accuracy of point-of-care urine culture and susceptibility testing(14 months)
研究者
Anne Holm
MD PhD-student
University of Copenhagen